Nevro Corp.Download PDFPatent Trials and Appeals BoardJun 9, 2021IPR2021-00295 (P.T.A.B. Jun. 9, 2021) Copy Citation Trials@uspto.gov Paper 16 571-272-7822 Date: June 9, 2021 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD BOSTON SCIENTIFIC CORP., AND BOSTON SCIENTIFIC NEUROMODULATION CORP., Petitioner, v. NEVRO CORP., Patent Owner. IPR2021-00295 Patent 9,002,461 B2 Before BARRY L. GROSSMAN, MITCHELL G. WEATHERLY, and JAMES A. WORTH, Administrative Patent Judges. WORTH, Administrative Patent Judge. DECISION Denying Institution of Inter Partes Review 35 U.S.C. § 314 I. INTRODUCTION A. Background and Summary On December 7, 2020, Boston Scientific Corp. and Boston Scientific Neuromodulation Corp. (collectively, “Boston Scientific” or “Petitioner”) filed a Petition (Paper 1, “Pet.”) requesting an inter partes review of IPR2021-00295 Patent 9,002,461 B2 2 claims 1–8 and 10–17 (the “challenged claims”) of U.S. Patent No. 9,002,461 B2 (Ex. 1001, “the ’461 patent”). On March 15, 2021, Nevro Corp. (“Nevro” or “Patent Owner”) filed a Preliminary Response (Paper 9, “Prelim. Resp.”). With authorization, the parties filed further pre-institution briefing related to the issue of discretion under 35 U.S.C. § 314(a), as follows. On April 5, 2021, Petitioner filed a reply to the Preliminary Response. Paper 11. On April 12, 2021, Patent Owner filed a sur-reply. Paper 13. On May 25, 2021, Petitioner filed a second reply to the Preliminary Response. Paper 14. Petitioner relies on the declaration of Richard T. Mihran, Ph.D. Ex. 1008. Institution of an inter partes review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 311 and any response filed under [35 U.S.C. §] 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). For the reasons set forth below, we determine that Petitioner has not shown that there is a reasonable likelihood that any of claims 1–8 and 10–17 is unpatentable based on the Petition, and we deny the Petition. In particular, we determine that Petitioner has not shown a reasonable likelihood that any of the prior art discloses the following limitation of independent claim 1, “automatically set the waveform parameter applied to the second electrode based on a relationship between the first therapy range and the second therapy range” (referred to below as limitation 1[h]). More particularly, Petitioner has not adequately explained how the claim language maps onto the cited prior art. Independent claim 11 contains a corresponding limitation. Petitioner’s argued grounds of anticipation and IPR2021-00295 Patent 9,002,461 B2 3 obviousness are therefore deficient. We explore Petitioner’s argued grounds in more detail below. B. Real Parties in Interest Petitioner identifies Boston Scientific Corp. and Boston Scientific Neuromodulation Corp. as real parties-in-interest. See Pet. 1. Patent Owner identifies Nevro Corp. as a real-party-in-interest. Paper 4, 1. C. Related Matters The parties note as related litigation in federal district court, Boston Scientific Corp. et al v. Nevro Corp., Nos. 16-cv-1163, 18-cv-00644 (consolidated) (D. Del.). See Pet. 1; Paper 4, 1. Petitioner has filed a petition for inter partes review challenging U.S. Patent No. 9,002,460 (IPR2021-01562) and U.S. Patent No. 10,076,665 (IPR2020-01563). See Pet. 1; Prelim. Resp. 11. According to Patent Owner, the ’461 patent is related to the following other patents and applications: 8,712,535, 8,498,710, 9,409,019, 9,827,423, 10,220,210, 10,786,672, and 16/944,841. Paper 4, 1. D. The ’461 Patent The ’461 patent is titled “Linked Area Parameter Adjustment for Spinal Cord Stimulation and Associated Systems and Methods” and is directed “to spinal cord stimulation for managing pain, and associated systems and methods related to adjusting the amplitude, duty cycle and/or other parameters of the electrical waveform applied to the patient.” Ex. 1001, 1:21–25. The ’461 patent describes that then-existing pulse generator devices applied electrical pulses to electrodes, which altered a patient’s responsiveness to sensory stimuli and/or altered the patient’s nervous system’s motor-circuit output. Id. at 1:44–48. The ’461 patent describes that many patients reported tingling or paresthesia that was perceived as less IPR2021-00295 Patent 9,002,461 B2 4 uncomfortable than the patients’ underlying pain sensation, but many other patients reported less beneficial effects and/or results. Id. at 1:50–54. The ’461 patent thus describes a need for improved techniques and systems for addressing pain. Id. at 1:55–56. According to the ’461 patent, one particular challenge of implementing neurological stimulators to manage pain was that multiple parts or regions of the patient’s body contribute to the pain perceived by the patient, and the individual contributions of the various regions vary over time. Id. at 1:57–61. Figure 1A of the ’461 patent is reproduced below: Figure 1A is a partially schematic illustration of an implantable spinal cord stimulation system positioned at the spine to deliver therapeutic signals. Id. at 2:3–6. Waveform generator 101 can be connected directly to lead IPR2021-00295 Patent 9,002,461 B2 5 body 110, or it can be coupled to lead body 110 via communication link 102 (e.g., an extension). Id. at 5:5–8. The ’461 patent discloses that during the trial period and the course of the spinal cord stimulation (SCS) therapy itself, the patients typically change the parameters of the waveforms applied to different areas along the spinal cord to optimize the therapy. Id. at 2:61–64. In some embodiments, the present technology includes an electrode device having a plurality of electrodes including at least a first electrode associated with a first area of the patient and a second electrode associated with a second area of the patient. The first area has a first therapy range for a waveform parameter, and the second area has a second therapy range for the waveform parameter. Id. at 3:29–31. The level of a waveform parameter applied to each area in a linked pair can be modulated based upon a scaling factor between the corresponding areas. Id. at 6:41–44. The ’461 patent discloses that when the amplitude is the waveform parameter being modulated, the ratio of the first therapy range for the first area of the patient to the second therapy range for the second area of the patient can be defined by the equation: Ex. 1001, 10:66–11:7. In this equation, A1P is the amplitude at which the patient experiences pain at the first area, A1T is the amplitude at which the patient experiences a therapeutic effect at the first area, A2P is the amplitude at which the patient experiences pain at the second area, and A2T is the amplitude at which the patient experiences a therapeutic effect at the second area. Id. at 11:8–14. In this embodiment, the change in the level of the IPR2021-00295 Patent 9,002,461 B2 6 waveform parameter applied to the second area is the product of the magnitude of the first increment that the waveform parameter was changed at the first area and the ratio of the first therapy range to the second therapy range. Id. at 11:14–19. By way of an example where there is a ratio of a first therapy range to a second therapy range of 3:2, each time the patient pushes a button to increase or decrease the waveform parameter, the waveform parameter for the first electrode is changed by a full increment, but the waveform parameter is changed at the second area only every two out of three times that the patient pushes the button. See id. at 11:47–58. In one particular example, the computer program is programmed to change the level of the waveform parameter applied to the first electrode implanted at the first area of the patient to an updated first level, automatically set the second level of the waveform parameter based on a ratio or other relationship between the first therapy range and the second therapy range to an updated second level, and deliver the electrical waveform at the updated first level to the first electrode and at the updated second level to the second electrode. Id. at 4:36–45. In several embodiments, the method includes changing the level of the waveform parameter applied to the first electrode and concurrently setting the level of the waveform parameter applied to the second electrode, but in other embodiments there can be a delay between changing the level of the waveform parameter applied to the first electrode and setting the level of the waveform parameter applied to the second electrode. Id. at 7:47–54. E. Illustrative Claim Claims 1 and 11 are the independent claims challenged in the Petition. Claim 1, reproduced below, is illustrative of the subject matter: IPR2021-00295 Patent 9,002,461 B2 7 1. [a] A system for managing pain in a patient using an electrical waveform, comprising: [b] an electrode device configured to be implanted into a patient and including a plurality of electrodes [c] having at least a first electrode associated with a first area of the patient and a second electrode associated with a second area of the patient, [d] wherein the first area has a first therapy range for a waveform parameter and the second area has a second therapy range for the waveform parameter; and [e] an implantable device configured to be coupled to the electrode device, [f] the implantable device including a power supply, a waveform generator configured to generate a waveform, and a computer-operable medium operatively coupled to the waveform generator, [g] the computer-operable medium being programmed to change the waveform parameter applied to the first electrode and [h] automatically set the waveform parameter applied to the second electrode based on a relationship between the first therapy range and the second therapy range. Ex. 1001, 14:12–31 (reproduced with added paragraphing and paragraph letter designations in brackets). F. Prior Art and Asserted Grounds Petitioner asserts that claims 1–8 and 10–17 would have been unpatentable on the following 23 grounds (Pet. 4–5): Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis 1–4, 7, 8, 10–17 102 Meadows1 1 Meadows, US 6,516,227 B1, iss. Feb. 4, 2003 (Ex. 1003, “Meadows”). IPR2021-00295 Patent 9,002,461 B2 8 Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis 1–8, 10–17 1032 Meadows 1–8, 10–17 103 Meadows, John3 6–8 103 Meadows, Goetz4 6–8 103 Meadows, John, Goetz 1–4, 7, 8, 10–17 102 Thacker5 1–8, 10–17 103 Thacker 1–8, 10–17 103 Thacker, Meadows 1–8, 10–17 103 Thacker, John 1–8, 10–17 103 Thacker, Meadows, John 6–8 103 Thacker, Goetz 6–8 103 Thacker, Meadows, Goetz 6–8 103 Thacker, John, Goetz 6–8 103 Thacker, Meadows, John, Goetz 1–4, 10–17 102 Nolan6 1–8, 10–17 103 Nolan 1–8, 10–17 103 Nolan, Meadows 1–8, 10–17 103 Nolan, John 1–8, 10–17 103 Nolan, Meadows, John 6–8 103 Nolan, Goetz 6–8 103 Nolan, Meadows, Goetz 6–8 103 Nolan, John, Goetz 6–8 103 Nolan, Meadows, John, Goetz We observe that several of the 23 grounds were argued in the alternative. For example, the asserted ground of anticipation by Meadows 2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat. 284, 287–88 (2011), amended 35 U.S.C. §§ 102 and 103. It is undisputed on this record that the priority date of the ’461 patent is July 28, 2009. See Pet. 14; Prelim. Resp. 5. Because the ’461 patent was filed before the effective date of the relevant amendment, the pre-AIA version of §§ 102 and 103 applies. 3 John, US 2007 /0043401 A1, pub. Feb. 22, 2007 (Ex. 1006, “John”). 4 Goetz, US 2006/0235472 A1, pub. Oct. 19, 2006 (Ex. 1007, “Goetz”). 5 Thacker, US 9,278,222 B2, iss. Mar. 8, 2016 (Ex. 1004, “Thacker”). 6 Nolan, US 2007/0213789 A1, pub. Sept. 13, 2007 (Ex. 1005, “Nolan”). IPR2021-00295 Patent 9,002,461 B2 9 was based on two argued scenarios and “in addition . . . other ways” in which Meadows is argued to disclose a limitation. See Pet. 32–35. Further, the asserted grounds of anticipation by Thacker, obviousness over Thacker, and obviousness over Meadows were argued based on Thacker’s system implementing an aspect of Meadows or Meadows’s system using a feature of Thacker. See, e.g., Pet. 59. Thus, there are in effect more than 23 argued grounds. Nevertheless, for purposes of the above summary chart, we have summarized the asserted grounds as the 23 grounds listed above.7 II. ANALYSIS A. Legal Standards A “prior art reference—in order to anticipate under 35 U.S.C. § 102— must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). “A single prior art reference may anticipate without disclosing a feature of the claimed invention if such feature is necessarily present, or inherent, in that reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed. Cir. 2014). “[A]nticipation by inherent disclosure is appropriate only when the [single prior art] reference discloses prior art that must necessarily include the unstated limitation.” Transclean Corp. v. Bridgewood Servs., Inc., 290 7 We note that the Petitioner also had multiple theories of the case inasmuch as the asserted grounds were characterized by string citations to numerous portions of the record. Some of these citations spanned columns of text. See, e.g., Pet. 33 (citing Ex. 1012, 12:10–15:16, 16:3–18:2, 20:5–24:24), 80 (citing Ex. 1005 ¶¶ 52–69, 78–98), 81 (citing id. at claims 1–17, 32–38). IPR2021-00295 Patent 9,002,461 B2 10 F.3d 1364, 1373 (Fed. Cir. 2002) (citation omitted). “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Cont’l Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991) (internal quotation marks and citations omitted). Rather, “[t]he inherent result must inevitably result from the disclosed steps.” In re Montgomery, 677 F.3d 1375, 1380 (Fed. Cir. 2012). A patent claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. 35 U.S.C. § 103; KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR, 550 U.S. at 416 (citing United States v. Adams, 383 U.S. 39, 50‒51 (1966)). The question of obviousness is resolved based on underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of non-obviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). In an inter partes review, a petition must identify “with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence that supports the grounds for the challenge to each claim.” 35 U.S.C. § 312(a)(3); see also 37 C.F.R. § 42.104(b) (2020) (requiring a petition for inter partes review to identify how the challenged IPR2021-00295 Patent 9,002,461 B2 11 claim is to be construed and where each element of the claim is found in the prior art patents or printed publications relied upon). B. Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art (POSA) at the relevant times would have had a degree in engineering, biomedical engineering, or a related discipline, along with relevant experience (at least 2–3 years for a Ph.D., 3–5 years for a Master’s, or greater than 5 years for a Bachelor’s degree) researching or developing neural stimulation systems or other implantable medical devices. Pet. 13–14 (citing Ex. 1008 ¶¶ 20–22). Petitioner argues that a person of ordinary skill alternatively would have had an M.D. and experience practicing as a neurologist, neurosurgeon or anesthesiologist, with 2–3 years of experience in neural stimulation. Id. at 14. Petitioner argues that the person would have had general knowledge of implantable medical devices and various related technologies as of July 28, 2009. Id. Patent Owner does not contest Petitioner’s definition of the ordinary level of skill at this time but reserves the right to challenge Petitioner’s formulation should trial be instituted. Prelim. Resp. 7. For purposes of this Decision, we adopt Petitioner’s undisputed definition. C. Claim Construction We construe each claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b). Under this standard, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the IPR2021-00295 Patent 9,002,461 B2 12 entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner provides the proposed constructions of the terms “based on a relationship” and “computer-operable medium” that were argued in related litigation. Pet. 14–15. Patent Owner does not propose any constructions and argues that the Board need not adopt Petitioner’s argued constructions. Prelim. Resp. 7. We construe “based on a relationship” because it relates to a key disputed limitation in this proceeding. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (claims are construed only to the extent necessary to resolve a dispute). “based on a relationship” According to Petitioner, Nevro argued in District Court that “relationship” and “based on a relationship” were “non-technical, ordinary” phrases. Pet. 14 (citing Ex. 1022). Boston Scientific argued in District Court that “relationship” means “ratio or other scaling factor.” See id. (citing Ex. 1001, 3:41–4:45, 7:3–15:18, Figs. 6–7). Boston Scientific argued in District Court that “based on a relationship” means “using the product of the magnitude of the first increment (i.e., the change to the waveform parameter applied to the first electrode) and the relationship,” based on the Specification. See Pet. 14–15 (citing Ex. 1001, 7:13–29, 10:66–11:36, 12:61–66, Fig. 4); Ex. 1022, 22–25. Petitioner argues that this is the only way of setting the parameter for the second electrode disclosed in the Specification. See id. Petitioner also argues that “Nevro also limited the claims to this embodiment during prosecution.” Pet. 15 (citing id. § IV.C.). Patent Owner argues that “Petitioner’s litigation-driven constructions of ‘relationship’ / ‘based on a relationship’ were correctly rejected in district IPR2021-00295 Patent 9,002,461 B2 13 court and need not be adopted here.” Prelim. Resp. 7 (citing Ex. 2001, 5; Ex. 2003, 133:17–135:15). The District Court construed “based on a relationship” to have its plain and ordinary meaning. Ex. 2001, 5. We construe “based on a relationship” to have its plain and ordinary meaning, in agreement with the District Court construction. We have reviewed the cited portions of the Specification relied on by Boston Scientific and determine that they do not rise to the level of a definition of “relationship” or “based on a relationship” although the Specification provides a definition for a specific “ratio.” See Ex. 1001, 7:13–29 (setting the level of the waveform parameter applied to the second electrode based on the magnitude of the change of the waveform parameter applied to the first electrode and a relationship between the first therapy range and the second therapy range), 10:66–11:36 (providing an equation with the ratio of the first therapy range for the first area of the patient to the second therapy range for the second area of the patient), 12:61–66 (method 70 includes changing the first level of the waveform parameter and setting the second level of the waveform parameter), Fig. 4 (schematic illustrations of waveforms). Petitioner also refers to the section of its brief on the prosecution history and appears to argue that in related U.S. Patent Application 12/510,930 (“the ’930 Application”), the applicant amended the claims to include a “mathematical relationship” and stated that “the claims should be read to cover the embodiments of mathematical relationships described in the specification and all equivalents thereof.” Pet. 12–13 (citing Ex. 1011, 197, 207–09). IPR2021-00295 Patent 9,002,461 B2 14 Whether or not that statement rises to the level of a clear and unequivocal disclaimer in the ’930 Application, the term “mathematical relationship” does not appear in the claims of the ’461 patent. Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017) (“In general, a prosecution disclaimer will only apply to a subsequent patent if that patent contains the same claim limitation as its predecessor.”) (citation omitted). Petitioner states that, although the ’461 patent claims lack the term “mathematical relationship” which was present in the ’930 Application, the Examiner referred to a “mathematical relationship” in the notice of allowance for the ’461 patent. Pet. 12–13 (citing Ex. 1002, 99). We find the Examiner’s notice of allowance to be insufficient evidence of an intent by the applicant to limit the claims of the ’461 patent to a mathematical relationship. See, e.g., Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366 (Fed. Cir. 2008) (“a patentee may limit the meaning of a claim term by making a clear and unmistakable disavowal of scope during prosecution”) (citation omitted). Whether or not a relationship can be mathematical (see Prelim. Resp. 30), we do not find a clear and unmistakable disclaimer for the ’461 patent to limit the claim scope to a mathematical relationship.8 We, therefore, agree with the District Court’s construction that “based on a relationship” has its plain and ordinary meaning. 8 Even if the claims were limited to a “mathematical relationship,” this would not change our conclusion that Petitioner has not shown a reasonable likelihood of prevailing on its assertion as to any of the claims of the ’461 patent. IPR2021-00295 Patent 9,002,461 B2 15 D. Anticipation of Claims 1–4, 7, 8, and 10–17 by Meadows Petitioner contends that claims 1–4, 7, 8, and 10–17 are anticipated by Meadows. Pet. 16–50, 55–59. Patent Owner disagrees. See Prelim. Resp. 34–51. 1. Meadows Meadows is titled “Rechargeable Spinal Cord Stimulator System” and relates to a spinal cord stimulation (SCS) system, which is a programmable implantable pulse generating system used to treat chronic pain by providing electrical stimulation pulses from an electrode array placed epidurally near a patient’s spine. Ex. 1003, code (54), 1:9–13. Meadows discloses that its SCS system provides a stimulus to a selected pair or group of a multiplicity of electrodes, e.g., 16 electrodes, grouped into multiple channels, e.g., four channels. Id. at 2:46–50. Each electrode is able to produce a programmable constant output current of at least 10 mA over a range of output voltages that may go as high as 16 volts. Id. at 2:50–52. In a preferred embodiment, the implant portion of the SCS system includes a rechargeable power source, e.g., a rechargeable battery that allows the patients to go about their daily business unfettered by an external power source and controller. See id. at 2:54–57. Meadows discloses that, as a feature of its system, each of the electrodes included within the stimulus channels may not only deliver up to 12.7 mA of current over the entire range of output voltages, but also may be combined with other electrodes to deliver even more current. Id. at 2:65–3:2. Meadows discloses, in one embodiment, that the SCS system provides the ability to stimulate simultaneously on all available electrodes. Id. at 3:2– 4. Each electrode is grouped with at least one additional electrode. Id. at IPR2021-00295 Patent 9,002,461 B2 16 3:4–5. In one embodiment, such grouping is achieved by a low impedance switching matrix that allows any electrode contact or the system case (which may be used as a common, or indifferent, electrode) to be connected to any other electrode. Id. at 3:5–9. In another embodiment, Meadows discloses programmable output current DAC’s (digital-to-analog converters) are connected to each electrode node, so that, when enabled, any electrode node can be grouped with any other electrode node that is enabled at the same time, thereby eliminating the need for the low impedance switching matrix. Id. at 3:9–14. This feature thus allows the clinician to provide unique electrical stimulation fields for each current channel. Id. at 3:14–17. Meadows discloses that, whichever type of lead and electrode array is used, an important feature of its SCS system is the ability to support more than one lead with two or more channels. Id. at 10:20–23. Here, a “channel” is defined as a specified electrode, or group of electrodes, that receive a specified pattern or sequence of stimulus pulses. Id. at 10:23–25. Where more than one “channel” is available, each channel may be programmed to provide its own specified pattern or sequence of stimulus pulses to its defined electrode or group of electrodes. Id. at 10:25–29. Meadows discloses that it is advantageous to have multiple channels, for example, because left and right sides, or upper and lower extremities, may require different stimulus parameter settings. Id. at 10:34–37. Meadows discloses that monopolar and bipolar sensitivity (max and min) thresholds may then be determined for each electrode for the displayed electrode array configuration, with the aid of amplitude, rate (frequency), and pulse width settings. Id. at 34:9–14. IPR2021-00295 Patent 9,002,461 B2 17 Meadows also states that “[i]n one embodiment, maximum and minimum thresholds map to amplitude levels designated by numbers from 1 to 10 for each electrode (with respect to monopolar or bipolar or multipolar configurations), as described in U.S. Patent Application Serial No. 60/172,167, filed Dec. 17, 1999[9], incorporated herein by reference.” Id. at 34:14–19. Meadows also states that “details associated with programming the IPG [implantable pulse generator] may be found in U.S. Pat. No. 6,052,624, U.S. patent application Ser. No. 09/550,217, filed Apr. 17, 2000[10]; and U.S. Patent Application Serial No. 60/172,167, filed Dec. 17, 1999, which patent and applications are incorporated herein by reference.” Id. at 29:62–66.11 2. Analysis of Independent Claim 1 For the following reasons, we determine that Petitioner has not shown a reasonable likelihood that Meadows discloses the limitation “automatically set the waveform parameter applied to the second electrode based on a relationship between the first therapy range and the second therapy range” (limitation 1[h]). Petitioner presents at least two “scenarios” of how it argues that Meadows discloses limitation 1[h]. See Pet. 33–34. For the reasons set 9 Ex. 1012, hereinafter “Mann167.” 10 Ex. 1013, hereinafter “Mann217.” 11 In arguing for anticipation by Meadows, Petitioner also relies on the disclosures of Mann167 and Mann217 as incorporated by reference. See Pet. 19. Patent Owner argues that Meadows fails to incorporate the disclosure from Mann217 relied on by Petitioner and reserves the right to challenge Meadows’s incorporation of Mann167 in the event that the Board institutes trial. Prelim. Resp. 38 n.8, 41–45. For purposes of this Decision, and except as noted below, we need not decide the extent to which Meadows incorporates by reference Mann217 and Mann167. IPR2021-00295 Patent 9,002,461 B2 18 forth below, we determine that these “scenarios” are hypothetical examples constructed by Petitioner for how to program an IPG that lack an adequate basis in Meadows. We will analyze each scenario in turn. a) Petitioner’s asserted “scenario one” First, Petitioner asserts a “scenario one”: a user sends a command to change the amplitude for a channel (e.g., from level 1 to 2), and the IPG changes the amplitude applied to the first electrode in the channel (e.g., to its level 2 magnitude), and automatically sets the amplitude applied to the second electrode (and any other electrodes) in the channel (e.g., to its level 2 magnitude) based on a therapy range ratio. Pet. 33 (citing Ex. 1003, 5:48–60, 10:20–33, 18:41–53, 33:66–34:23, 35:5–62, 37:21–41, 38:41–56; Ex. 1012, 2:10–29, 6:18–7:8, 12:10–15:16, 16:3–18:2, 20:5–24:24, Figs. 3A–3B, 5–6). In other words, Petitioner is referring to a scenario in which the IPG sets the amplitude of multiple electrodes in the same electrode channel. See Ex. 1008 ¶ 102 (scenario (1) when adjusting the magnitude level of a single channel containing the first and second electrodes).12,13 Patent Owner argues that Petitioner fails to demonstrate that the waveform parameter applied to the second electrode is based on the therapy range of the first electrode because Petitioner fails to demonstrate that the waveform parameter applied to the second electrode in Meadows or Mann167 can be affected in any way by the therapy range for the first 12 We understand the channel to be a combination or set of electrodes. 13 Petitioner’s argued “scenario one” (see Pet. 33) is not referring to sequential steps but rather to a command that simultaneously adjusts the amplitude for each electrode in the channel. See Ex. 1008 ¶ 104. Indeed, Mann167 simply applies an equalized magnitude level to all electrodes in the same set. See Ex. 1012, 22:18–23:6. IPR2021-00295 Patent 9,002,461 B2 19 electrode. Prelim. Resp. 36–37 (citing Geospan Corp. v. Pictometry Int’l Corp., No. CIV. 08-816 ADM/JSM, 2011 WL 1261583, at *6 (D. Minn. Mar. 31, 2011), aff'd, 469 F. App’x 913 (Fed. Cir. 2012)). We are persuaded by Patent Owner. Meadows refers to and incorporates Mann167’s programming of electrodes, set at unit-less magnitude levels 1–10. See Ex. 1003, 33:66–34:23. Mann167 discloses setting magnitude levels 1 to 10 for each electrode, where the perception threshold is set to magnitude level 1 and the maximum tolerable threshold is set to magnitude level 10, with 8 steps in between. Ex. 1012, 6:18–7:8, 13:9–27. Claim 9 of Mann167 describes a method of (a) measuring a perception threshold and a maximum tolerable threshold for each of n electrode contacts; (b) equalizing those thresholds to unit-less magnitude levels; (c) applying a stimulus having a selected equalized magnitude level to a selected combination of n electrode contacts; (d) determining whether the stimulus applied in step (c) produces a desired result and if not selecting a different equalized magnitude level and repeating step (c); and (e) if the stimulus applied in step (c) produces a desired result, then selecting the stimulus parameters as the optimal set of stimulus parameters that are programmed into the implantable neural stimulator. See Ex. 1012, 22:18– 23:6. If and when step (d) causes Mann167 to repeat step (c), Mann167 changes the magnitude levels for each of the electrode contacts in the same set of electrodes. Id. at 22:28–23:3. Although the ’461 patent provides an express use of the therapy ranges of the first and second electrodes to set the amplitude for each electrode when changing the amplitude for a first electrode (see Ex. 1001, 10:55–11:16), Mann167 discloses no such relationship. As Patent Owner states, Mann167 discusses generally how IPR2021-00295 Patent 9,002,461 B2 20 magnitude levels map to amplitude, but does not disclose any dependency or relationship between electrodes. See Prelim. Resp. 37 (citing Ex. 1012, 13:10–14:20). Petitioner has not shown that Mann167 sets the amplitude for the second electrode based on a relationship between a first electrode’s therapy range and a second electrode’s therapy range, as opposed to using another method to set the amplitude for a second electrode. In this connection, we note that Mann167 provides the following equation (1): I = (M-P)/9E *(X-1) + P/E, where X = Magnitude Level (0–10); I = mA for electrode (n); P = Perception Threshold, mA; M = Maximum Threshold, mA; and E = number of cathodic electrodes in a group. See Ex. 1012, 16:14–25. Mann167 states that “Magnitude Level X remains constant for all electrodes that become selected by the up/down input, while individual current levels are input for each selected electrode based on the formula presented above. Id. at 17:2–5 (emphasis added). Thus, when Mann167 sets the magnitude of a given electrode to a desired magnitude level, it may set the current based on the therapy range of that electrode and the desired magnitude level (see id. at 16:14–25, 17:2–5).14 Petitioner argues that the amplitude for the second electrode is set based on a therapy range ratio of a first and second electrode, giving an example: a therapy range of 2 to 8 mA for the first electrode at Area A1, and 14 There is a discussion in Mann167 of summing the amplitude levels for adjacent electrodes assigned to a “virtual” cathode. See Ex. 1012, 17:6–27. However, Petitioner did not provide reasoning in the text of the Petition based thereon, and we find that such unexplained citations contained in longer string cites to be an inadequate basis for Petitioner to rely on these portions of Mann167. IPR2021-00295 Patent 9,002,461 B2 21 a therapy range of 3 to 7 mA for the second electrode at Area A2, resulting in therapy range ratio or scaling factor S1 of 3:2 where S1 = (8–2)/(7-3) = 6/4 = 3/2. See Pet. 34 (citing Ex. 1012, 2:10–29, 12:10–14:20, 16:3–18:2; citing Ex. 1008 ¶¶ 104–106). It is unclear from where Petitioner and Petitioner’s expert derives this equation. Dr. Mihran appears to obtain the numbers for the therapy ranges from the therapy ranges of electrode 1 and electrode 2 in Figure 5 of Mann167. See Ex. 1008 ¶ 90 (discussing limitation 1[d]). However, there is no disclosure of a scaling factor in Mann167, and Dr. Mihran does not demonstrate that Mann167 necessarily makes use of a scaling factor. Transclean Corp. v. Bridgewood Servs., Inc., 290 F.3d 1364, 1373 (Fed. Cir. 2002) (“[A]nticipation by inherent disclosure is appropriate only when the [single prior art] reference discloses prior art that must necessarily include the unstated limitation.”). Nor does Dr. Mihran explain how his equations would be derived from the equations in Mann167. Figure 5 of Mann167 is reproduced below: IPR2021-00295 Patent 9,002,461 B2 22 Figure 5 is a graph illustrating a representative stimulating current distribution for first and second electrodes as a function of amplitude (magnitude) level. Ex. 1012, 7:26–27. Figure 5 does show therapy ranges of 2 mA to 8 mA for electrode 1, and 3 mA to 7 mA for electrode 2. However, Mann167 does not show the use of a scaling factor to calculate the current levels, as Petitioner argues. There may be a relationship between the therapy range of the first electrode and the second electrode inasmuch as the minimum thresholds are equalized by being set equal to a magnitude level 1, and the maximum thresholds are equalized by being set equal to a magnitude level 10, with a linear increase for magnitude levels 2–9. Id. at 12:10–15:16. Thus, there will always be a correlation between the amplitude levels for each electrode. However, Petitioner has not shown that the amplitude for the second electrode is set based on the therapeutic range for the first electrode. IPR2021-00295 Patent 9,002,461 B2 23 The portions of Mann167 relied on do not disclose a scaling factor or otherwise show that a parameter for a second electrode is set based on a relationship between therapy ranges. See Ex. 1012, 2:10–29 (discussing the need for a neural stimulator where parameters may be met quickly and safely), 12:10–14:20 (determining the magnitude levels for each electrode set based on its minimum and maximum threshold), 16:3–18:2 (providing equation (1) for a magnitude level, with current I, magnitude level X, perception threshold P, maximum threshold M, and number of cathodic electrodes E, where I = (M-P) (X-1)/9E + P/E; discussing virtual cathode based on summation of electrode quantities)). Petitioner has provided insufficient evidence and explanation to demonstrate that Mann167 makes use of a scaling factor when it sets the current level of a second electrode, as opposed to using other methods. For completeness of discussion, we have reviewed the remaining portions of Meadows cited by Petitioner and determine that they do not disclose that a second electrode’s amplitude is set based on a relationship between first and second therapy ranges. Rather, Meadows merely indicates that each electrode is set to an amplitude corresponding to a desired level (1 to 10) where the therapy range (minimum to maximum) of that electrode is divided into 10 steps. See Ex. 1003, 5:48–60 (the hand held programmer may change the stimulus parameters), 10:20–33 (device has the ability to support one lead with two or more channels), 18:41–53 (electrodes may be assigned to groups and amplitudes on a channel may vary), 33:66–34:23 (an electrode may have a threshold window with a minimum and a maximum, and levels 1 to 10 for each electrode as described in Mann167), 35:5–62 (the amplitude may be selected from 1 to 10), 37:21–41 (settings may be changed IPR2021-00295 Patent 9,002,461 B2 24 by telemetry), 38:41–56 (level 0 is off and level 1 is set to the sense threshold). Also for completeness of discussion, we have reviewed the remaining portions of Mann167 cited by Petitioner and determine that they do not disclose the recited relationship. See Ex. 1012, 6:18–7:8 (setting the perception threshold as the minimum, setting the maximum tolerable threshold as the maximum and assigning 10 levels), 12:10–15:16 (the perception thresholds are equalized by mapping the perception threshold and maximum tolerable threshold into unit-less “magnitude level” settings 1 and 10, with magnitude levels 2–9 set for a linear increase), 20:5–24:24 (claims 1–15 of Mann167), Figs. 3A–3B (showing therapeutic range for each electrode a, b, c, and d, and magnitude levels 1–10 for each), 5–6 (showing tabular data and graphical data for electrodes 1 and 2). We therefore determine that Petitioner has not made an adequate showing that Meadows necessarily discloses limitation 1[h] by changing the magnitude level of the electrodes in the same channel. b) Petitioner’s asserted “scenario two” Petitioner asserts a “scenario two”: the IPG changes the amplitude applied to the first electrode in a first channel (e.g., from level 1 to 2), and when the IPG sequences to a second channel, it automatically sets the amplitude applied to the second electrode in the second channel (e.g., to its respective level 2 amplitude) based on a therapy range ratio. Pet. 33–34 (citing Ex. 1012, 2:10–3:25, 4:11–5:3, 12:10–14:20, 15:17–16:2, 18:19–19:5, Figs. 4–6). In other words, Petitioner is referring to a scenario in which the IPG sets the amplitude of electrodes in different channels. See Ex. 1008 ¶ 102 (scenario (2) when sequencing (or switching) stimulation IPR2021-00295 Patent 9,002,461 B2 25 from a first channel containing the first electrode to a second channel containing the second electrode). Patent Owner argues that Petitioner makes no attempt to explain how the waveform parameter applied to a second electrode in a second channel is automatically set “based on a relationship” between the second electrode’s therapy range and any therapy range of an electrode in the first channel. Prelim. Resp. 39–40. We are persuaded by Patent Owner. As already discussed above with respect to “scenario one,” Mann167 merely discloses equalizing the magnitude level of the electrode contacts within a given selected combination of electrode contacts. Ex. 1012, 4:11–5:3. Mann167 also discloses equalizing the therapeutic range across electrode sets “a” through “d.” Id. at 12:17–13:27, Figs. 3A, 3B. However, Mann167 does not necessarily stimulate a second channel at a magnitude level equal to a first channel, or based on any particular relationship between the channels. Instead, Mann167 discloses “sequenc[ing]” through selected electrode sets, or combinations of electrodes, at “various” magnitude levels in order to determine which combinations of electrodes and stimulus parameters produce a desired result. Id. at 15:17–20. In any event, Petitioner has not shown that a second electrode in a second set of electrodes (or channel) is set based on the therapy range of a first electrode in a first set of electrodes (or channel), let alone a relationship between first and second therapy ranges.15 15 Mann167 explains that its improvement is that “[b]y adjusting the magnitude of the applied stimulus in terms of the ‘magnitude level’ number, rather than the actual current value” “the fitting process (i.e., the process of trying to locate the optimum stimulation parameters and electrode set) may IPR2021-00295 Patent 9,002,461 B2 26 Petitioner argues that “scenario two” makes use of the same scaling factor or therapy range ratio that Petitioner asserts for “scenario one” (see Pet. 34–35), but this argument fails for similar reasons. Petitioner has not shown that Mann167 makes use of a scaling factor nor has Petitioner shown how its proffered equations for a scaling factor may be derived from Mann167’s disclosure. We have reviewed the portions of Mann167 cited by Petitioner and determine that they do not show setting a second electrode based on a relationship between the therapy ranges of the first and second electrodes. See Ex. 1012, 2:10–3:25 (background section indicates that there was a need for a method of equalizing the perceived amplitude, and to thereby enable quick, automated, and/or interactive (i.e., directional programming) methods), 4:11–5:3 (same steps as claim 9 of Mann167 discussed above in which step (c) of the method applies a selected equalized magnitude level to a combination of n electrode contacts and step (d) of the method repeats step (c) by applying a different equalized magnitude level), 12:10–14:20 (threshold data for sets “a” through “d,” once measured during an initial set up period, are “equalized” so that the equalized threshold levels may thereafter be used as further testing continues to determine the optimum stimulus parameters), 15:17–16:2 (once the magnitude levels for each electrode or electrode set have been determined, the IPG 30 is controlled so as to sequence through selected electrode sets, or combinations of electrodes, at various magnitude levels in order to determine which combinations of electrodes and stimulus parameters produce a desired be carried out much quicker and safer than has heretofore been possible.” Ex. 1012, 15:25–16:1. IPR2021-00295 Patent 9,002,461 B2 27 result), 18:19–19:5 (programming system or method is advantageously included as a key part of the invention whereby the perceived magnitude of the applied stimuli is equalized in order to enable quick, automated, and/or interactive selection of the stimulation parameter values that are used by the stimulator), Fig. 4 (high level flowchart that depicts method as described elsewhere, e.g., id. at 12:21–15:20), Figs. 5–6 (summation of electrode 1 and electrode 2). We therefore determine that Petitioner has not made an adequate showing that Meadows necessarily discloses limitation 1[h] when switching between channels. c) Petitioner’s asserted interpolation of therapy ranges Petitioner additionally asserts that Meadows, through incorporation by reference of Mann217, discloses interpolating a therapy range for an electrode placed between two other electrodes. Pet. 35–37. Petitioner’s contentions are illustrated with further reference to the annotated figure below. IPR2021-00295 Patent 9,002,461 B2 28 Figure 13 of Mann217, annotated by Petitioner, is provided above with color added by Petitioner. Id. at 36. Petitioner asserts that the IPG can interpolate the therapy range (in red) for the second electrode (in green) at Area A2 based on a therapy range (in orange) (the “second therapy range”) associated with Area A2 and a therapy range (in purple) (the “first therapy range”) associated with Area A1. Id. at 35–36 (citing Ex. 1013, 28:4–29:3, 38:11–22, 40:7–20, 43:9–44:21; Ex. 1008 ¶ 107). Petitioner asserts that once the interpolated therapy range (in red) is mapped to levels 1 to 10 and a user adjusts from one level to another, the IPG will automatically set the amplitude of the second electrode (in green) using the interpolated range IPR2021-00295 Patent 9,002,461 B2 29 derived from and set based on the first and second therapy ranges (in purple and orange). Id. at 36. Patent Owner argues that Petitioner fails to demonstrate how interpolating therapy ranges discloses the claimed “based on a relationship” requirement because Petitioner’s theory relies on different “second therapy ranges” for different parts of the claims. Prelim. Resp. 45. Claim 1 recites (i) “a second electrode associated with a second area of the patient, wherein … the second area has a second therapy range for the waveform parameter,” and (ii) “automatically set[ting] the waveform parameter applied to the second electrode based on a relationship between the first therapy range and the second therapy range.” Id.; Ex. 1001, 14:17–21, 14:29–31. Patent Owner argues that the recited “second therapy range” is both (i) the therapy range for the area that the “second electrode” is associated with, and also (ii) part of the “relationship” used to set the waveform parameter for the “second electrode.” Prelim. Resp. 45. Patent Owner argues that Petitioner does not identify any “second therapy range” that is both (i) the therapy range for the area that the “second electrode” is associated with, and also (ii) part of the “relationship” used to set the waveform parameter for the “second electrode.” Id. at 46. Patent Owner also argues that Petitioner’s mapping of Mann217 to the claims mapping implausibly relies on “Area A2” having multiple therapy ranges for the same waveform parameter and Mann217 does not identify any area that has more than one therapy range. Id. at 47–48. We are persuaded by Patent Owner that Petitioner has failed to show that a parameter for a second electrode is set based on a relationship between a first therapy range and second therapy range, where the second electrode is associated with a second area and the second area has a second therapy IPR2021-00295 Patent 9,002,461 B2 30 range. See Ex. 1001, 14:14–21, 14:29–31. Petitioner identifies the green electrode as the second electrode, and the purple range as the first therapy range. In order to rely on a first and second therapy range to determine the therapy range in red for the second electrode (in green), Petitioner relies on the orange therapy range as the second therapy range, but this is not consistent with the claim language because the orange therapy range (the argued second therapy range) is not associated with the second electrode and this interpretation is therefore inconsistent with the claim language. Summary of Claim 1 On the record at this stage of the proceeding, we determine that Petitioner has not shown a reasonable likelihood that claim 1 of the ’461 patent is anticipated by Meadows. 3. Analysis of Remaining Claims We determine that Petitioner has not shown a reasonable likelihood that dependent claims 2–4, 7, 8, and 10 are anticipated by Meadows, for the same reasons as independent claim 1. Independent claim 11 contains similar language and requirements as limitation [h] of independent claim 1. For the same reasons as independent claim 1, we determine that Petitioner has not shown a reasonable likelihood of prevailing on its assertion of anticipation by Meadows as to independent claim 11 and its dependent claims 12–17. E. Obviousness of Claims 1–8 and 10–17 over Meadows To remedy the above-identified deficiency in Meadows as to limitation 1[h], Petitioner’s assertion of obviousness of claim 1 over Meadows is based on the disclosure of the ’461 patent that there were conventional devices that automatically set a parameter for linked areas having therapy ranges. See Pet. 37–39 (citing, e.g., Ex. 1008 ¶¶ 110–112). IPR2021-00295 Patent 9,002,461 B2 31 Petitioner argues that “no modification of the hardware is necessary to program the claimed ‘relationship’—it is just math implemented in programming and therefore a predictable design choice—a POSA would have a reasonable expectation of success.” Id. Petitioner also asserts that automatically setting the second electrode based on a “ratio … equal to 1:1” (the claimed “relationship”) was also well-known, according to the ’461 patent. Pet. 38 (citing Ex. 1001, 3:14–18, 10:54–57, 13:59–63). Patent Owner argues that the existence of linked mode systems, however, in no way concedes that it was known to set a second waveform parameter “based on a relationship” between first and second therapy ranges as claimed. Prelim. Resp. 50. Patent Owner states that the cited portion of the ’461 patent is from a section describing the invention of the ’461 patent, explaining that “[t]he ratio of the first therapy range to the second therapy range can be less than 1:1, equal to 1:1, or greater than 1:1 depending upon the sizes of the individual ranges.” Id. (citing Ex. 1001, 10:54–57). Patent Owner argues that this can hardly show it was known to set a second waveform parameter “based on a relationship” between first and second therapy ranges as claimed. Id. We have reviewed the portions of the ’461 patent relied on by Petitioner and find that they do not disclose setting a second electrode based on a relationship between first and second therapy ranges. For example, the ’461 patent criticizes conventional linking mode systems that adjust the amplitudes equally because different areas have different maximum amplitude thresholds above which patients can experience pain. See Ex. 1001, 3:14–18. This does not, however, disclose using the maximum and minimum thresholds of therapy ranges to automatically set a parameter. The ’461 patent discloses that the ratio of the first therapy range can be less IPR2021-00295 Patent 9,002,461 B2 32 than 1:1, equal to 1:1, or greater than 1:1 depending on the sizes of the individual ranges. Id. at 10:54–57. We agree with Patent Owner that this does not teach the use of a specific ratio, much less teach automatically setting a parameter of a second electrode based on a relationship between therapy ranges, as recited. The ’461 patent also states that existing linked mode systems change the intensity of the waveform parameter at different electrodes by equal increments or allow waveform parameters to be decreased from their maximums by equal increments. Id. at 13:59–63. This does not teach using a relationship between a first and second therapy range to set a parameter. Petitioner provides no persuasive evidence or argument why it would have been obvious to modify Meadows to add the missing element, i.e., limitation 1[h]. Accordingly, we determine that Petitioner has not shown a reasonable likelihood that independent claim 1 would have been obvious over Meadows, for similar reasons as for its asserted ground of anticipation by Meadows. Petitioner has not shown a reasonable likelihood that claims 2–8 and 10–17 would have been obvious over Meadows, for the same reasons as independent claim 1. F. Obviousness of Claims 1–8 and 10–17 over Meadows and John Petitioner contends that claims 1–8 and 10–17 would have been obvious over Meadows and John. Pet. 39–59. Patent Owner disagrees. See Prelim. Resp. 51–54. 1. John John is titled “Systems and Methods for Treating Disorders of the Central Nervous System by Modulation of Brain Networks” and relates to “modulation of the central nervous system for treating brain disorders and more particularly to modulation of brain networks associated with IPR2021-00295 Patent 9,002,461 B2 33 undesirable aspects or symptoms of a patient’s brain disorder.” Ex. 1006, code (54), ¶ 2. John discloses that its system is intended to address the interactions and connectivity that exists between different brain regions of a brain network. See id. ¶ 8. John’s system provides deep brain stimulation treatment that adjusts for the activation of multiple regions of a network which may or may not be stimulated directly. Id. John’s system uses neuromodulation methods that control (e.g., rebalance) the relative activation levels of different areas of the network. Id. John discloses that linking rules can be used to address the effects of indirect or secondary stimulation. Id. ¶ 128. “Indirect stimulation” effects can occur at locations which are sufficiently distal from the site of stimulation that these areas are not directly stimulated by, for example, the electrical field of a stimulator. Id. That being said, the use of linking rules does not necessitate direct connectivity between the regions which are being stimulated. Id. ¶ 129. In one embodiment, neuromodulation of a network occurs by modulating at least a first neural target region (i.e., NT1) and a second neural target region (NT2), which are part of a network underlying, or significantly correlated with, at least one characteristic of a disorder for which treatment is being sought. Id. ¶ 131. One example of “linked stimulation” is that when at least one stimulation parameter for stimulating NT1, for example, voltage level, is increased by 1 volt then simultaneously the neuromodulation of NT2 is increased by 0.5 volts. Id. Whenever NT1 is additionally increased by 1 volt, then NT2 is increased by 0.5 volts. Id. The “linking rule” is that Vnt2=Vntl *0.5, where Vntl is equal to the voltage used at target NT1, and Vnt2 is equal to the voltage used at target NT2. Id. IPR2021-00295 Patent 9,002,461 B2 34 John discloses that linking rules are important because changes within the network, that occur as side-effects in other regions due to stimulation of a target structure, may aid, hinder, be irrelevant to, or may compensate for neuromodulation treatment in the target region. Id. ¶ 133. 2. Analysis of Claim 1 Petitioner argues that John teaches “automatically adjusting stimulation to a second area if the stimulation in a first area is adjusted by the patient,” e.g., increasing the stimulation “proportionately for the two areas, as defined by the linking rule.” Pet. 41 (citing Ex. 1006 ¶¶ 138, 144). Petitioner argues that this means that, like in the ’461 patent, the first increment for a first electrode is used in the “linking rule” to calculate and automatically set the parameter applied to the second electrode. Id. Petitioner argues that it would have been obvious to program Meadows’ IPG using John’s “linking rule” technique to “automatically set the waveform parameter applied to the second electrode based on a relationship between the first therapy range and the second therapy range.” Id. at 41 (citing Ex. 1008 ¶¶ 114–18). Petitioner argues that Specifically, the combined teachings of Meadows and John render obvious programming Meadows’ IPG with a “linking rule,” so that when a user changes the amplitude of the first electrode, the IPG automatically sets the amplitude applied to the second electrode based on a therapy range ratio—e.g., according to a “linking rule” that uses the product of the first increment and the therapy range ratio. Id. at 41–42. Patent Owner argues that Petitioner fails to demonstrate, or even assert, that John discloses automatically setting a second waveform parameter “based on a relationship” between first and second therapy ranges. Prelim. Resp. 52. Patent Owner argues that, at most, Petitioner alleges that IPR2021-00295 Patent 9,002,461 B2 35 John discloses automatically setting a second waveform parameter “based on a relationship” between first and second waveform parameters, not therapy ranges as claimed. Id. We have reviewed the evidence relied on by Petitioner, and we are persuaded by Patent Owner that John fails to disclose setting a second waveform parameter “based on a relationship” between first and second therapy ranges. The cited portions of John disclose that linking rules may be used to adjust the stimulation at one target region to compensate for cascading effects of stimulation of another region in a neural network and show that a parameter may increase proportionally for the two areas but do not disclose doing so based on first and second therapy ranges. Paragraph 9 of John discloses, e.g., “linking rules to adjust the stimulation provided at one target region according to the neurostimulation provided at a different target region, where both regions are part of a brain network.” Ex. 1006 ¶ 9. Paragraph 20 of John discloses that John’s object is to provide a method of neuromodulation which uses linking rules to link the neuromodulation protocol of one stimulated area to those used at a different modulated area. Id. ¶ 20. Paragraph 46 of John discloses evaluating sensed data and using it to create a stimulation signal as may occur through control laws. Id. ¶ 46. Paragraph 48 of John discloses that reference values may refer to values determined by an equation, fixed values, or ratios. Id. ¶ 48. Paragraph 108 of John discloses that correlation analysis of data from brain networks can be used to guide neurostimulation protocols, where the aim is not to increase or decrease the overall level of activity, but rather to alter the timing and correlation of activity between the two regions of the brain network. Id. ¶ 108. Paragraph 113 of John discloses that a treatment protocol can incorporate information about the inter-region interactions. Id. ¶ 113. Cited IPR2021-00295 Patent 9,002,461 B2 36 paragraphs 127–140 of John consist of multiple paragraphs discussing, e.g., that there can be indirect stimulation of brain regions and providing examples of linking rules where a first parameter is multiplied by a constant to arrive at a second parameter. Id. ¶¶ 127–140. Paragraph 144 of John discloses that patients can modify linking rules. Id. ¶ 144. Paragraphs 149– 150 of John disclose modulating at least a first region and a second region of a brain network, wherein the stimulation protocol of a first region is modified due to data sensed in, or stimulation that is provided at, at least a second region of the network. Id. ¶¶ 149–150. Thus, we agree with Patent Owner that John merely discloses changing the parameter of a second electrode based on a parameter of a first electrode, e.g., multiplied by a constant (see, e.g., id. ¶ 131), but does not disclose setting a parameter of a second electrode based on a relationship between first and second therapy ranges. For these reasons, John does not remedy the deficiency in the asserted ground of obviousness over Meadows. Accordingly, we determine that Petitioner has not shown a reasonable likelihood that claim 1 is obvious over Meadows and John. 3. Analysis of Remaining Claims We determine that Petitioner has not shown a reasonable likelihood that claims 2–8 and 10–17 are obvious over Meadows and John, for the same reasons as independent claim 1. G. Obviousness of Claims 6–8 over Meadows and Goetz; Obviousness of Claims 6–8 over Meadows, John, and Goetz Petitioner contends that claims 6–8 are obvious over Meadows and Goetz, or over Meadows, John, and Goetz. Pet. 52–56. Patent Owner disagrees. See Prelim. Resp. 54. IPR2021-00295 Patent 9,002,461 B2 37 1. Goetz Goetz is titled “Therapy Programming Guidance Based on Stored Programming History” and relates to “the delivery of therapy by medical devices and, more particularly, to programming the delivery of therapy by medical devices.” Ex. 1007, code (54), ¶ 2. Goetz describes a problem with existing systems, i.e., printed records and clinician memory of previous programming sessions are often absent or inadequate, and provided little assistance in more quickly identifying desirable programs during a current programming session. Id. ¶ 7. Goetz discloses that programming history may be maintained or accessed by a programming device used to program delivery of therapy to a patient by a medical device, and may take the form of a record of programs, e.g., combinations of therapy parameters, tested during one or more prior programming sessions. Id. ¶ 8. Goetz discloses that during a current programming session, the programming device may retrieve information relating to the extent or times of use for one or more programs that were sent home with the patient. Id. ¶ 11. 2. Analysis of Claims 6–8 Petitioner does not rely on Goetz to remedy the above-identified deficiency in the grounds of obviousness of independent claim 1 over Meadows, alone or further in view of John. Accordingly, we determine that Petitioner has not shown a reasonable likelihood that dependent claims 6–8 would have been obvious over Meadows and Goetz, or obvious over Meadows, John, and Goetz, for the same reasons as for the grounds of obviousness over Meadows and over Meadows and John. IPR2021-00295 Patent 9,002,461 B2 38 H. Anticipation of Claims 1–4, 7, 8, and 10–17 by Thacker16 Petitioner contends that claims 1–4, 7, 8, and 10–17 are anticipated by Thacker. Pet. 59–69. Patent Owner disagrees. See Prelim. Resp. 54–56. 1. Thacker Thacker is titled “System and Method For Converting Tissue Stimulation Programs in a Format Usable by an Electrical Current Steering Navigator” and relates “tissue stimulation systems, and more particularly, to a system and method for programming an implantable tissue stimulator.” Ex. 1004, code (54), 1:16–18. Thacker discloses a method of programming a controller that controls electrical stimulation energy output to a plurality of electrodes. Id. at 4:47– 48. Thacker discloses, in the background section, that by reprogramming an external control device, the stimulation region can often be moved back to the effective pain site without having to reoperate on the patient in order to reposition the lead and its electrode array. Id. at 3:9–12. Thacker also discloses in the background section that an exemplary navigation table (Appendix A), which includes a series of reference electrode combinations (for a lead of 8 electrodes) with associated fractionalized current values (i.e., fractionalized electrode configurations), can be used to gradually steer electrical current from one basic electrode combination to the next, thereby electronically steering the stimulation region along the leads. Id. at 3:41–47. 16 Petitioner argues together the grounds of anticipation by Thacker; obviousness over Thacker; and obviousness over Thacker and Meadows. See Pet. 62–69. IPR2021-00295 Patent 9,002,461 B2 39 Figure 21 of Thacker is reproduced below: Figure 21 is a first navigator programming screen that can be displayed by the computerized programming system of Figure 6 (not reproduced here). Id. at 7:39–41. Actuation of navigator button 112 opens a navigator screen 100(7) that allows a clinician to shift current between multiple electrode combinations to fine tune and optimize stimulation coverage for patient comfort. Id. at 17:17–20. Clicking on up and down control arrows 204, 206 displaces horizontal bar 212, and thus location designator 214, up and down within navigator scope 202, and clicking on the left and right control arrows 208, 210 displaces location designator 214 left and right along the horizontal bar 212. Id. at 17:28–33. In one embodiment, the steering table in Appendix A is used to shift the cathodic and anodic currents up and down along each lead 12 using simultaneously delivered IPR2021-00295 Patent 9,002,461 B2 40 pulses (and in this case, by using fractionalized current values in each row of the steering table to generate stimulation in only one timing channel). Id. at 18:4–9. For example, to gradually shift from a fractionalized current value configuration of 100% cathodic current on electrode E1 and 100% anodic current on electrode E3 to 100% cathodic current on electrode E1 and 100% anodic current on electrode E4, fractionalized electrode configurations will be stepped through. Id. at 18:9–15. Figure 15 of Thacker is reproduced below: Figure 15 is a fifth operating room mapping screen that can be displayed by the computerized programming system of Figure 6, particularly showing an electrode combination in a manual mode. Id. at 7:17–20. IPR2021-00295 Patent 9,002,461 B2 41 A right arrow button can be clicked to incrementally increase the pulse rate of the stimulation energy, and the left arrow of which can be clicked to incrementally decrease the pulse rate of the stimulation energy. Id. at 14:57–62. Notably, the adjustment of the pulse amplitude, pulse width, and pulse rate will be performed globally for all of the electrodes activated as either an anode (+) or a cathode (-). Id. at 14:62–65. 2. Analysis of Claim 1 Petitioner sets forth argument and evidence for its assertions that claim 1 is anticipated by Thacker. Pet. 62–69. Patent Owner disagrees. Prelim. Resp. 54–56. Petitioner argues that Thacker incorporates Meadows and “thus discloses and renders obvious these claims for the same reasons.” Pet. 59, 62 (citing Ex. 1004, 10:19–23). Petitioner argues that Thacker discloses an SCS system like Meadows and adds “a third scenario” where an IPG is programmed to automatically set the waveform parameter applied to the second electrode based on a therapy range ratio—i.e., a “global” adjustment feature that allows simultaneously changing and setting a parameter not only across multiple electrodes, but also across multiple channels. Id. (citing Ex. 1008 ¶¶ 161–197). Petitioner argues that Thacker discloses (and renders obvious)17 this third scenario in at least two ways: (1) Meadows’ system using Thacker’s “global” adjustment feature, and (2) Thacker’s system using Meadows’ “therapy ranges.” Id. Petitioner argues that Thacker provides a “global” adjustment feature that allows the user to adjust a parameter (e.g., amplitude), automatically and 17 See n.16, supra. IPR2021-00295 Patent 9,002,461 B2 42 simultaneously, for two or more coverage areas based on a therapy range ratio. Id. at 61–62 (citing Ex. 1004, 2:64–3:12, 15:10–67, 19:47–61, 20:24–30, Figs. 16–20). Petitioner argues that “the Thacker-Meadows IPG can provide stimulation simultaneously on multiple channels.” Id. at 65 (citing Ex. 1004, 1:64–2:7, 2:64–3:12, 15:10–30). Petitioner argues that “Thacker teaches that, by selecting a ‘global’ button, a user may select two or more coverage areas and ‘globally’ adjust a parameter (e.g., amplitude) simultaneously for the electrodes in multiple selected areas based on a therapy range ratio between those areas, as explained for limitation [1h] in the Meadows grounds.” Pet. 66 (citing Ex. 1004, 2:64–3:12, 14:57–65, 15:10–67, 19:47–61, 20:24–30, Figs. 16–20; Ex. 1008 ¶ 181). According to Petitioner: When the user sends a change command to the Thacker- Meadows IPG using “global” adjustment, the IPG is programmed to change the parameter (e.g., amplitude) applied to the first electrode in the first channel (e.g., from level 1 to 2), and automatically set the parameter of the second electrode in the second channel (e.g., amplitude at level 2) based on a therapy range ratio (e.g., 3:2 ratio), as explained for limitation [1h] in the Meadows grounds. Pet. 67–68. Patent Owner argues that, even if Thacker incorporates Meadows by reference, Petitioner fails to demonstrate that the Thacker-Meadows combination discloses automatically setting a second waveform parameter “based on a relationship” between first and second therapy ranges. Prelim. Resp. 56. Patent Owner argues that Petitioner relies on a channel-wide change command (Thacker’s “global” adjustment) that changes the parameters applied to two electrodes in parallel, and that Petitioner’s theory IPR2021-00295 Patent 9,002,461 B2 43 is almost exactly the same as Meadows’ “scenario one.” Id. Patent Owner argues that Petitioner’s theory fails to demonstrate that Thacker or Meadows discloses any dependency between an electrode’s waveform parameter and another electrode’s therapy range, let alone that its waveform parameter is automatically set “based on a relationship” between first and second therapy ranges. Id. We agree with Patent Owner that Thacker’s global adjustment changes the parameters applied to two electrodes in parallel and that Petitioner has not demonstrated that the waveform parameter for a second parameter is necessarily set based on the relationship between first and second therapy ranges as opposed to using another method. We have reviewed the evidence relied on by Petitioner and find that the cited portions do not demonstrate such a relationship. The cited portions of Thacker disclose that parameters may be adjusted and may be combined into a single stimulation program. See Ex. 1004, 2:64–3:12 (reprogramming can move the treatment area without repositioning electrodes), 14:57–65 (adjustment of pulse amplitude, pulse width, and pulse rate can be performed globally), 15:10–67 (example of parameters; multiple coverage areas can be activated; the clinician can modify the electrical pulse parameters output by the IPG to the electrode array for a selected coverage area; global button can allow clinician to modify the pulse amplitude of selected coverage areas), 19:47–61 (can increase or decrease amplitude), 20:24–30 (groups of stimulation parameter sets can be combined into a single stimulation program), Figs. 16–20 (depicting screens). We therefore conclude that Thacker’s global adjustment does not necessarily disclose that a parameter is set for a second electrode based on the relationship between first and second therapy ranges. IPR2021-00295 Patent 9,002,461 B2 44 Further, based on our discussion in Section II.D.2. above, Petitioner has not shown how the use of Meadow’s therapy ranges would necessarily disclose that a parameter is set for a second electrode based on the relationship between first and second therapy ranges. Accordingly, we determine that Petitioner has not shown a reasonable likelihood that independent claim 1 is anticipated by Thacker. 3. Analysis of Remaining Claims We determine that Petitioner has not shown a reasonable likelihood that claims 2–4, 7, 8, and 10–17 are anticipated by Thacker, for the same reasons as independent claim 1. I. Obviousness of Claims 1–8 and 10–17 over Thacker; Obviousness of Claims 1–8 and 10–17 over Thacker and Meadows Petitioner sets forth argument and evidence for its assertions that claims 1–8 and 10–17 are obvious over Thacker, alone or further in view of Meadows. Pet. 62–69. Patent Owner disagrees. Prelim. Resp. 56–58. 1. Analysis of Claim 1 Petitioner’s contentions for obviousness over Thacker, alone or further in view of Meadows, are similar to Petitioner’s contentions for anticipation by Thacker. These grounds were grouped together in the Petition. In addition to asserting that Thacker incorporates Meadows by reference, Petitioner argues that a person of ordinary skill would have been motivated to combine Meadows with Thacker. See Pet. 68. Patent Owner argues that Petitioner fails to identify any specific feature with respect to the combination of Thacker and Meadows, and performs none of the analysis required to present a prima facie case of obviousness. Prelim. Resp. 56–57 (citing TRW Automotive US LLC v. Magna Elecs. Inc., IPR2014-00257, Paper 16 at 9–11 (PTAB June 26, IPR2021-00295 Patent 9,002,461 B2 45 2014)). Patent Owner argues that Petitioner’s challenge entirely fails to explain what is missing from Meadows or Thacker and what it is proposing to add. Id. at 57. Patent Owner argues that even if it would have been obvious to incorporate “therapy ranges” from Meadows into Thacker or a “global” command from Thacker into Meadows, Petitioner still would fail to demonstrate that the Thacker-Meadows combination discloses setting a waveform parameter “based on a relationship” with another electrode’s therapy range, for the reasons provided elsewhere. Id. at 57 (citing id. §§ V.B.1, VI.B). For similar reasons as for the asserted ground of anticipation by Thacker (which Petitioner asserts to incorporate Meadows), we determine that Petitioner has not adequately shown that Thacker, alone or in combination with Meadows, discloses limitation 1[h]. Petitioner provides no persuasive evidence or argument why it would have been obvious to modify Thacker to add the missing element, i.e., limitation 1[h]. Accordingly, we determine that Petitioner has not shown a reasonable likelihood of prevailing on the asserted grounds. 2. Analysis of Remaining Claims For the same reasons as for claim 1, we determine that Petitioner has not shown a reasonable likelihood that claims 2–8 and 10–17 would have been obvious over Thacker, alone or further in view of Meadows. J. Obviousness of Claims 1–8 and 10–17 over Thacker and John; Obviousness of Claims 1–8 and 10–17 over Thacker, Meadows, and John Petitioner contends that claims 1–8 and 10–17 are obvious over Thacker, alone or further in view of Meadows, and further in view of John. See Pet. 69–73. Patent Owner disagrees. Prelim. Resp. 56–59. IPR2021-00295 Patent 9,002,461 B2 46 Because we find that John does not remedy the deficiency in the grounds of obviousness over Thacker, alone or further in view of Meadows, we determine that Petitioner has not shown a reasonable likelihood that claims 1–8 and 10–17 would have been obvious over Thacker, alone or further in view of Meadows, and further in view of John. K. Obviousness of Claims 6–8 over Thacker and Goetz; Obviousness of Claims 6–8 over Thacker, Meadows, and Goetz; Obviousness of Claims 6–8 over Thacker, John, and Goetz; Obviousness of Claims 6–8 over Thacker, Meadows, John, and Goetz; Petitioner does not rely on Goetz to remedy the above-identified deficiencies in the grounds of obviousness of independent claim 1 over Thacker, alone or further in view of one or more of Meadows and John. Accordingly, Petitioner has not shown a reasonable likelihood that dependent claims 6–8 would have been over Thacker, alone or further in view of one or more of Meadows and John, and further in view of Goetz. L. Anticipation of Claims 1–4 and 10–17 by Nolan18 Petitioner contends that claims 1–4 and 10–17 are anticipated by Nolan. Pet. 73–80. Patent Owner disagrees. See Prelim. Resp. 59–61. 1. Nolan Nolan is titled “Global Parameter Adjustment for Multiple Stimulation Programs” and relates “to medical devices and, more particularly, to devices that deliver electrical stimulation.” Ex. 1005, code (54), ¶ 1. Nolan discloses that a patient may enter a single command into an external programmer to make a parameter change on a “global” basis among a plurality of stimulation programs. Id. ¶ 5. Nolan discloses that a 18 Petitioner interweaves its arguments for anticipation by Nolan and obviousness over “Nolan, alone and with Meadows and/or John.” See Pet. 76. IPR2021-00295 Patent 9,002,461 B2 47 multiprogram adjustment eliminates the need for the patient to manually adjust the amplitude for each individual stimulation program. Id. ¶ 24. Figure 8 of Nolan is reproduced below: Figure 8 is a conceptual diagram illustrating an exemplary screen shot associated with a group of stimulation programs with a pop-up screen indicating a global parameter adjustment. Id. ¶ 20. Global icon 102 indicates to patient 12 that a global adjustment has been made, i.e., that the voltage amplitude for all programs in group A has been changed. Id. ¶ 90. Parameter variable 104 indicates the number of times patient 12 has selected to increase or decrease the voltage amplitude. IPR2021-00295 Patent 9,002,461 B2 48 In other words, parameter variable 104 is the number of increments or decrements made to the voltage amplitude of each program in group A. Id. Once the global adjustment has been initiated, processor 48 determines the adjustment range and step values for each program within the group selected. Id. ¶ 94. Processor 48 then goes through the programs to be adjusted. Id. If the program is not at a predetermined limit, processor 48 adjusts the voltage amplitude, or other specified parameter, one step. Id. Nolan discloses that the step for each program may be of equal or varying amplitude, dependent on the predetermined rules governing global adjustment. Id. ¶ 56. In one embodiment, the step size is a function of the adjustment range divided by the resolution. Id. ¶ 60. In an alternative embodiment, the global adjustment may cause the voltage amplitude of each stimulation program to change proportionately to one another. In this embodiment, the global adjustment will change the voltage amplitude of each stimulation program such that the ratios of each voltage will remain constant while using the global adjustment. Id. ¶ 64. In this embodiment, the step value of the selected program is calculated to match the ratio of the first voltage amplitude values of each program in the group so that the second voltage amplitudes of each program are proportional to the first voltage amplitudes. Id. ¶ 65. 2. Analysis of Claim 1 Petitioner sets forth argument and evidence for its assertions that claim 1 is anticipated by Nolan. Pet. 76–83. Patent Owner disagrees. Prelim. Resp. 59–61. Petitioner argues that Nolan teaches that electrodes, in any combination, are grouped into “programs” having therapy ranges and correlating to different areas, and the implantable medical device (IMD) IPR2021-00295 Patent 9,002,461 B2 49 provides stimulation simultaneously on multiple programs. Pet. 80 (citing Ex. 1005 ¶¶ 5, 26, 48). Petitioner argues that, Nolan (like Thacker) teaches that, with “global” adjustment, a user may select two or more programs and “globally” adjust a parameter (e.g., amplitude) simultaneously for the selected programs based on a therapy range ratio between those programs. Id. (citing Ex. 1005 ¶¶ 5–6, 26, 52–69, 78–98, Figs. 4A–4B, 6–9; Ex. 1008 ¶ 213. Petitioner asserts that Nolan discloses implementing “global” adjustment in the IMD. Id. at 81 (citing Ex. 1005 ¶¶ 10, 48–49, 99, claims 1–17, 32–38; Ex. 1008 ¶ 214). Petitioner asserts that [w]hen the user sends a change command to the IMD, it is programmed to change the parameter applied to the first electrode in the first program (e.g., from level 1 to 2), and automatically set the parameter of the second electrode in the second program (e.g., the amplitude at level 2) based on a ratio of the first and second therapy ranges (e.g., 3:2 ratio), as explained for limitation [1h] in the Meadows grounds. Id. (citing Ex. 1008 ¶ 214).19 19 Petitioner asserts that in March 2018, the European Opposition Division found a substantively identical claim to claim 1 of the ’461 patent lacked novelty in view of Nolan. Id. at 74 (citing Ex. 1030, 1–4, 10; Ex. 1031). Patent Owner also argues that the European Opposition Division finding is not binding or relevant to whether Petitioner has satisfied its burden in this proceeding. Id. at 60–61. In the European Opposition proceeding, an interlocutory decision made a finding that a similar limitation to limitation [1h] was known based on Nolan (Ex. 1030, 5, 7–8), and the patentee later agreed to an amendment. Ex. 1031, 8. In any event, we note that the European Opposition was based on a separate record with a separate set of arguments, and although we take the European Opposition into consideration, it is not binding. See, e.g., Walt Disney Co. v. Interactive Toybox, LLC, IPR2019-00609, Paper 10 (PTAB Aug. 21, 2019) (interpreting a claim differently than a corresponding claim in a corresponding EPO decision). IPR2021-00295 Patent 9,002,461 B2 50 Patent Owner argues that, as with the anticipation grounds based on Meadows and Thacker, Nolan’s change command fails to disclose setting a waveform parameter “based on a relationship” with another electrode’s therapy range because it fails to disclose any dependency between an electrode’s waveform parameter and another electrode’s therapy range, let alone that its waveform parameter is “based on a relationship” between first and second therapy ranges. Prelim. Resp. 60. We have reviewed the evidence and reasoning relied on by Petitioner and determine that Petitioner has failed to demonstrate a reasonable likelihood that Nolan discloses setting a parameter based on a relationship between first and second therapy ranges, as required by limitation 1[h]. Petitioner asserts that Nolan discloses that a single command makes the parameter change on a global basis among a plurality of stimulation programs. See Pet. 80 (citing Ex. 1005 ¶¶ 5–6). Paragraph 5 of Nolan does disclose the use of a single command to make the parameter change on a global basis. Ex. 1005 ¶ 5. However, for similar reasons as for the asserted grounds based on Meadows and Thacker, we determine that Petitioner has not shown that the use of a single command to change parameters in parallel necessarily means that a second electrode relies on the therapy range of a first electrode, as opposed to using another method. Paragraph 6 of Nolan discloses that each program may have a predetermined step value, a step value calculated based upon a remaining possible adjustment range, or a step value calculated for each stimulation program to keep parameter ratios equal between the plurality of stimulation programs during the global adjustment. Id. ¶ 6. However, Petitioner does not explain how keeping parameter ratios equal necessarily means that a parameter of a second electrode is automatically set based on the therapy range of a first electrode. IPR2021-00295 Patent 9,002,461 B2 51 Petitioner also does not adequately explain how the other proffered evidence discloses the required relationship. Paragraph 26 of Nolan discloses that programs may be delivered simultaneously or on a time- interleaved basis. Id. ¶ 26. Paragraphs 48–49 of Nolan disclose that adjustment instructions may include a set of rules and disclose wireless telemetry. Id. ¶¶ 48–49. Cited paragraphs 52–69 of Nolan consist of multiple paragraphs disclosing, e.g., that a range with a minimum and a maximum may be divided into 10 steps; the step may be a fixed value; alternatively the voltage amplitude of each program may change proportionately to one another; the step value may vary; and the ratio used to determine the step value for each of the other stimulation programs in the group is based on the first voltage amplitude of each stimulation program. Id. ¶¶ 52–69. Cited paragraphs 78–98 of Nolan consist of multiple paragraphs discussing a computer interface. Paragraph 99 of Nolan discloses a processor and memory for implementation. Id. ¶¶ 78–98. Cited claims 1–17 and 32–38 of Nolan consist of multiple claims, where, e.g., claim 12 discloses the steps of determining an adjustment range for a selected program; dividing the adjustment range for the selected program by a resolution value to determine a respective step value; dividing an existing parameter value for each of the other stimulation programs by the existing parameter value for the selected program to determine a ratio for each of the other stimulation programs; and multiplying the ratio for each of the other stimulation programs by the step value to determine respective scaled change values for each of the other stimulation programs, wherein applying the adjustment includes applying the step value to the existing parameter value for the selected program and applying the respective scaled change IPR2021-00295 Patent 9,002,461 B2 52 values to the existing parameter values for the other stimulation programs. Id. at 10–12. We agree with Patent Owner that, at most, Nolan describes a ratio of parameter values multiplied by a step value as opposed to a relationship between first and second therapy ranges. See Prelim. Resp. 62–63 (discussing obviousness over Nolan); Ex. 1005, claim 12. Dr. Mihran’s declaration does not provide any further explanation of how Nolan’s method would disclose setting a parameter of a second electrode based on a relationship between first and second therapy ranges. See Ex. 1008 ¶¶ 211–218. For example, Dr. Mihran states without further explanation that limitation [1h] is met by a ratio of a first therapy range to the second therapy range, e.g., 3:2, without explaining the basis for this averment, other than a string citation to portions of Nolan. See Ex. 1008 ¶ 214 (citing Ex. 1005 ¶¶ 10, 48–49, 99, claims 1–17, 32–38). As stated above, we have already reviewed paragraphs 48–49 and 99 and claims 1–17 and 32–38 of Nolan. Paragraph 10 of Nolan discloses a computer readable medium with instructions for applying an adjustment to a stimulation parameter. Ex. 1005 ¶ 10. We, therefore, determine that Petitioner has not adequately explained how Nolan discloses limitation [1h]. Accordingly, we determine that Petitioner has not shown a reasonable likelihood of prevailing on its assertion that claim 1 of the ’461 patent is anticipated by Nolan. 3. Analysis of Remaining Claims For the same reasons as independent claim 1, Petitioner’s has not shown a reasonable likelihood that claims 2–4 and 10–17 are anticipated by Nolan. IPR2021-00295 Patent 9,002,461 B2 53 M. Obviousness of Claims 1–8 and 10–17 over Nolan; Obviousness of Claims 1–8 and 10–17 over Nolan and Meadows Petitioner contends that claims 1–8 and 10–17 are obvious over Nolan, alone or further in view of Meadows. See Pet. 80–83. Patent Owner disagrees. See Prelim. Resp. 61–63. Petitioner groups its arguments for the asserted grounds of obviousness over Nolan and obviousness over Nolan and Meadows with the asserted ground of anticipation by Nolan. Pet. 80–83. Petitioner additionally argues that: If Nevro argues that Nolan does not disclose the “based on a relationship between the first therapy range and the second therapy range” limitation, it would have been obvious to program the Nolan IMD and Nolan-Meadows IMD, to automatically set the parameter of the second electrode based on the claimed relationship, e.g., setting the parameter in accordance with the therapy range ratio or, alternatively, using the product of the first increment and the therapy range ratio, for the same reasons in the Meadows grounds. Pet. 81–82 (citing id. § VII.B.[1h]; Ex. 1008 ¶ 216). Petitioner provides no persuasive evidence or argument why it would have been obvious to modify Nolan to add the missing element, i.e., limitation 1[h]. As set forth above, we determine that Petitioner has not adequately shown that Meadows discloses limitation 1[h]. See Section II.D.2. We determine that Petitioner has not shown that Nolan remedies the deficiency in Meadows, for the same reasons as for the asserted ground of anticipation by Nolan. Accordingly, we determine that Petitioner has not shown a reasonable likelihood that claims 1–8 and 10–17 would have been obvious over Nolan, alone or further in view of Meadows. IPR2021-00295 Patent 9,002,461 B2 54 N. Obviousness of Claims 1–8 and 10–17 over Nolan and John; Obviousness of Claims 1–8 and 10–17 over Nolan, Meadows, and John Petitioner contends that claims 1–8 and 10–17 are obvious over Nolan, alone or further in view of Meadows, and further in view of John. See Pet. 83–87. Patent Owner disagrees. Prelim. Resp. 63–64. Because we find that John does not remedy the deficiency in the grounds of obviousness over Nolan, alone or further in view of Meadows, we determine that Petitioner has not shown a reasonable likelihood that claims 1–8 and 10–17 would have been obvious over Nolan, alone or further in view of Meadows, and further in view of John. O. Obviousness of Claims 6–8 over Nolan and Goetz; Obviousness of Claims 6–8 over Nolan, Meadows, and Goetz; Obviousness of Claims 6–8 over Nolan, John, and Goetz; Obviousness of Claims 6–8 over Nolan, Meadows, John, and Goetz; Petitioner does not rely on Goetz to remedy the above-identified deficiencies in the grounds of obviousness of independent claim 1 over Nolan, alone or further in view of one or more of Meadows and John. Accordingly, we determine that Petitioner has not shown a reasonable likelihood that dependent claims 6–8 would have been obvious over Nolan, alone or further in view of one or more of Meadows and John, and further in view of Goetz. III. CONCLUSION We conclude that Petitioner has not shown a reasonable likelihood of prevailing on its assertion that any of claims 1–8 and 10–17 of the ’461 patent are unpatentable. Because of this, we need not reach the other issues raised by the parties, including the exercise of discretion under 35 U.S.C. §§ 314(a), 325(d). IPR2021-00295 Patent 9,002,461 B2 55 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied as to all challenged claims of the ’461 patent and no trial is instituted. IPR2021-00295 Patent 9,002,461 B2 56 FOR PETITIONER: Charles Rash Jason Weil Steven Maslowski Brooks Kenyon AKIN GUMP STRAUSS HAUER & FELD LLP brandon.rash@akingump.com jweil@akingump.com smaslowski@akingump.com bkenyon@akingump.com FOR PATENT OWNER: Ching-Lee Fukuda Thomas A. Broughan III SIDLEY AUSTIN LLP clfukuda@sidley.com tbroughan@sidley.com Jon Wright STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C. Jwright-PTAB@skgf.com IPR2021-00295 Patent 9,002,461 B2 57 Copy with citationCopy as parenthetical citation